<![CDATA[Dr. Shruti Bhat- Leader Pharmaceutical R&D.

<![CDATA[Dr. Shruti Bhat- Leader Pharmaceutical R&D. - BLOG LIBRARY]]>Fri, 24 May 2013 11:00:16 -0500Weebly<![CDATA[Test could detect a range of cancers weeks before symtoms]]>Thu, 08 Nov 2012 06:28:03 GMThttp://www.drshrutibhat.com/2/post/2012/11/test-could-detect-a-range-of-cancers-weeks-before-symtoms.htmlDNA targeting could pinpoint early cancers or deliver radiotherapy straight to the tumor. U.K. researchers have found a way to test for a protein that could become a biomarker for many different types of cancer. The DNA damage-signaling protein, γH2AX (gamma-H2AX), signposts the points where both strands of the DNA double helix have broken, one of the first steps in development of cancer (known as tumorigenesis).

The team from Oxford University's Gray Institute for Radiation Oncology and Biology has built an imaging probe that targets this protein. The probe is in three parts--an anti-γH2AX antibody that targets the biomarker, a peptide (TAT) that penetrates the cell, and 111In, a radioactive marker used as an imaging agent.

To test out the concept, the researchers used the probe and SPECT imaging to find DNA damage in a type of genetically modified mice that tend to develop breast cancer lumps that can be felt after around 17 weeks. The test spotted potential cancers in mice up to 5 weeks before they developed these lumps. The same marker is also seen in lung, skin, kidney and bladder cancer.

Katherine Vallis of the institute told BBC News: "If larger studies confirm this, the protein could provide a new route to detect cancer at its very earliest stage--when it is easier to treat successfully."

As well as being a biomarker for many cancers, this finding could also lead to a way to deliver radiotherapy directly to the damaged cells and monitor its effects, treating established tumors or even heading off cancers almost before they start. As Vallis explained to BBC News, the system is "self-amplifying" because the radiotherapy will cause further damage to the cells, therefore attracting more antibodies that will deliver more radiation, eventually killing the cancer cells. However, the technology has only been studied in mice so far, and it is a long way off use in humans.

]]><![CDATA[ Top 15 drug patent losses for 2013 ]]>Wed, 07 Nov 2012 03:46:34 GMThttp://www.drshrutibhat.com/2/post/2012/11/-top-15-drug-patent-losses-for-2013.htmlWe are in the midst of third quarter earnings reports, and they show with stark detail what the tsunami of patent losses means to the financial underpinning of drugmakers. It's a serious problem that will erode earnings for years to come. Pharmaceutical researcher EvaluatePharmaestimates there are $290 billion of sales at risk from patent expirations between this year and 2018.

Companies are trying to put the most positive spin they can on the impact, but the effects can take your breath away. For example, Sanofi , suggested in their company's most recent earnings call that things are looking up because its new full-year projection is for earnings to drop only 12% this year, not the 15% projected earlier. Sanofi lost protection for three drugs. Megablockbuster Plavix, a blood thinner, alone saw sales drop 70%.

And the patent cliff pain continues. In 2013, patents will expire on drugs that currently have sales of $29 billion annually. The research firm expects more than 70% of that total will be lost to generics. Falling revenue is usually tracked by a falling share price, but the firm points out that patent cliff problems, when a wave of big-ticket drugs lose protection, generally show up several years in advance with a stalling stock price.

The implications are, of course, huge. But is it all bad? "The patent cliff is generally portrayed as a bad event for the Industry, but it may turn out to be a good event, with companies feeling liberated from the mega-blockbuster curse of replacing aging cash flow
streams."

That depends, on how companies respond. Too often, spurred by the feeling they need to raise their share price--and perhaps made overconfident by the success of aging blockbusters--they blow it. They take excess cash from those aging cash cows and overindulge on "risky, late-stage, in-process R&D assets in seemingly high-priced and speculative in-licensing deals and company
acquisitions”.

Even those companies that say they are dedicated to finding their future with R&D don't always seem to know how. Statistics points out the industry has plunked down $1.1 trillion, in the last decade on research and development--and too often with very poor results.

So what are the drugs that top the 2013 patent expiry list? Presented here the top 15, out of about 120, that will see patents expire next year. It is led by Eli Lilly's anxiety and depression drug Cymbalta, which last year generated $4.9 billion in sales for the company. It includes Purdue Pharma'sOxyContin, which sold to the tune of $2.4 billion last year, and tails off with the Novartis osteoporosistreatment Reclast, which generated $612 million.

While the overall losses are less than this year's, which will see patent protection stripped away on about $67 billion, they will keep some companies in a vise grip of indecision. Others, perhaps, will free themselves and find their way to smart investments and drugs that provide benefits to patients and returns to shareholders. ]]><![CDATA[Drug Approvals Slipped in 2010 - Some Potential Blockbusters Suffered Delays Amid FDA's Tougher Safety Stance ]]>Tue, 04 Jan 2011 20:09:07 GMThttp://www.drshrutibhat.com/2/post/2011/01/drug-approvals-slipped-in-2010-some-potential-blockbusters-suffered-delays-amid-fdas-tougher-safety-stance.html

The Food and Drug Administration approved about 21 drugs in 2010, a relatively modest figure that shows the pharmaceutical industry hasn't yet escaped its drought in recent years.

A few potential blockbusters won approval during the year, but some of the most highly anticipated new products got delayed into next year or beyond. That partly reflects a tougher environment at the FDA, with regulators stepping up their scrutiny of safety issues in drugs for obesity, diabetes and other conditions.

According to monthly drug-approval reports on the FDA's website, 21 new drugs were approved in 2010, down from 25 in 2009 and 24 in 2008, but higher from a recent low of 18 in 2007.

More... http://pharmacy-education.blogspot.com/2011/01/drug-approvals-slipped-in-2010-some.html

References-

http://www.bloomberg.com/news/2010-12-30/new-drug-approvals-fell-in-2010-as-safety-concerns-slow-u-s-fda-decisions.html

http://online.wsj.com/article/SB10001424052748704543004576052170335871018.html?mod=googlenews_wsj

]]><![CDATA[United Kingdom: Deadline for Filing of Divisional Patent Applications]]>Tue, 28 Dec 2010 08:38:42 GMThttp://www.drshrutibhat.com/2/post/2010/12/united-kingdom-deadline-for-filing-of-divisional-patent-applications.html

]]><![CDATA[Mexican Patent Office Excludes Formulation Patents from Linkage Gazette]]>Sun, 26 Dec 2010 05:56:33 GMThttp://www.drshrutibhat.com/2/post/2010/12/mexican-patent-office-excludes-formulation-patents-from-linkage-gazette.html

]]><![CDATA[New Zealand: Prior Art Searching: The Importance Of Due Diligence In R&D Processes]]>Sat, 25 Dec 2010 04:40:38 GMThttp://www.drshrutibhat.com/2/post/2010/12/new-zealand-prior-art-searching-the-importance-of-due-diligence-in-rd-processes.html

]]><![CDATA[Is ‘hybrid model ' a good long-term strategy for drug-makers?]]>Wed, 22 Dec 2010 07:17:36 GMThttp://www.drshrutibhat.com/2/post/2010/12/is-hybrid-model-a-good-long-term-strategy-for-drug-makers.html

]]><![CDATA[How Will Expiring Drug Patents Affect Companies in the Healthcare Sector]]>Wed, 22 Dec 2010 07:13:52 GMThttp://www.drshrutibhat.com/2/post/2010/12/how-will-expiring-drug-patents-affect-companies-in-the-healthcare-sector.html

]]><![CDATA[Big pharma kisses its blockbuster years goodbye.]]>Wed, 22 Dec 2010 07:09:38 GMThttp://www.drshrutibhat.com/2/post/2010/12/big-pharma-kisses-its-blockbuster-years-goodbye.html

Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current patent news, views and data.

Industry giants are facing major new challenges as patents run out on many of the drugs that have kept them in clover.

Lipitor is one of the biggest-selling prescription drugs in the world. It is produced by the giant pharmaceutical company Pfizer and has revolutionised the treatment of patients with high cholesterol.

In 2009 Lipitor topped the best-selling prescription drug charts, generating $5.7bn in sales in the US and an additional $5.7bn outside the US. These revenues ultimately come from the drug's active ingredient, atorvastatin.

Lipitor is what is known in the industry as a classic "blockbuster drug".

The problem for Pfizer is that next year the patent to exclusively produce and sell Lipitor expires. This "coming off-patent" process will allow other companies to produce and sell generic copies of Lipitor, and it will take a hatchet to Pfizer's revenue stream from the drug.

Pfizer's pharmaceutical peers Sanofi-aventis and Bristol-Myers Squibb are facing a similar "generic erosion" of their widely used anti-clotting drug Plavix which comes off-patent next year.

But the real issue for the sector is that Lipitor and Plavix mark the start of a coming avalanche of expiring patents of blockbuster drugs over the next few years, known colloquially as the "patent cliff".

Some estimate that, over the next five years, drugs currently generating $142bn in sales annually will lose patent protection. The investment management firm AXA Framlington, meanwhile, has said that the leading pharmaceutical companies will lose between 14 per cent and 41 per cent of their existing revenues because of patent expiries.

And, despite record levels of investment in research and development by the big pharmaceutical companies, there appear to be few similar blockbuster drugs in the pipeline to plug the gaping revenue hole.

At a time when the world's population is getting bigger, older, and more likely to take prescription drugs, it seems counter-intuitive that the $518bn pharmaceutical sector could be entering an era of declining revenues and profits, however, it is a real possibility. The sector is preoccupied with its own evolution; and, as this analysis shows, the challenges, and potential risks and rewards, are immense.

Is the 'patent cliff' hype?

The "patent cliff" is the chief challenge facing the industry, although some companies will be affected more than others. Patents can sometimes be extended by making slight changes to the chemical composition, for example – a process called "ever-greening".

However, some analysts argue that the search for new blockbuster drugs is not good value for money. PricewaterhouseCoopers (PwC), in its report Pharma 2020: The Vision, says that industry leaders' revenues "have come at a very high price". It notes that between 1985 and 2000 the industry's market value increased 85-fold, outpacing the stock market as a whole. But in the six years to 30 March 2007 the FTSE global pharmaceuticals index rose just 1.3 per cent, while the Dow Jones World Index rose by 34.9 per cent. Additionally, it says that only five of the top companies worldwide generate more than 10 per cent of their revenues from products launched since 2001. "Even allowing for inflation, the industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced," it says.

Where will all the new drugs come from?

"The number of new medicines is at an all-time low and is as low as it has been since the Second World War," says Professor Clive Page, chairman of Verona Pharma.

The small biotech company is working on three drugs that alleviate symptoms of hayfever and chronic respiratory diseases, and is emblematic of the new breed of companies providing the innovation and stream of drugs that will feed the big pharma companies' supply chain.

Smaller start-up companies have lower costs, smaller teams, more efficient working processes, high scientific expertise and the ability to recognise and produce new molecular entities that could become tomorrow's breakthrough drugs. But it is the big pharma companies that have the financial might to buy or license new drugs and take them through the often expensive second and third phases of testing, with the aim of producing a viable commercial drug at the end.

Kevin Johnson, chief executive of PanGenetics, which last November sold an experimental drug for the treatment of chronic pain for $170m to Abbott Laboratories, says: "In my view, it is easier to develop a drug in a small company, at least in the early stages. From there the balance of power shifts; when you get to the later stages of testing the big companies are the right ones to do that. It is about playing to relative strengths".

Can the small companies provide these drugs?

Securing finance is difficult for any start-up business and particularly tricky in the field of science. Experimental drugs, by their nature, are risky and can fail; scientific discovery can be lengthy, expensive and difficult to explain to a financial backer looking for returns on equity and financial performance. The sector has also had a bad reputation for promising more than it can deliver.

This is why Francesco De Rubertis, a partner at the venture capitalist Index Ventures, says the developing division of labour between the big pharma companies and the biotech sector, and emerging collaborations with big academic institutions, should be encouraged. "A new equilibrium has to be reached. We are not there yet but in the long term I am optimistic," he says.

Said Darwazah, chief executive of the FTSE 250 pharmaceutical company Hikma, says the changing nature of the business is not surprising: "Why should a scientist work for £100,000 a year in a big pharmaceutical company when he can set up on his own, do exactly the same work, create a new product and sell it for £100m?"

Smaller companies also tend to be more businesslike about killing projects that don't work, says Professor Page. "In small companies, people don't have pet projects that they keep throwing money at."

Is finding new blockbuster drugs the only option for big pharma?

Discovering new drugs is not the only answer for the sector as there are new frontiers opening in emerging markets such as China, Turkey, the Middle East and North Africa.

Tim Edwards, chief executive of Cellzome, which is producing chemical proteomics technology that identifies new drugs to treat inflammatory diseases, comments: "The emerging markets could produce revenue which could be equal to the revenue streams lost from drugs coming off patent."

Kevin Johnson of PanGenetics adds: "One half of the merger and acquisition dollars that have gone into acquiring companies has been in the emerging markets sector."

Many companies that previously focused on branded products are also looking to tap into the growing generic drugs market by setting up their own generic-drug producing and licensing arms.

Regulatory environment-

Regulatory bodies and the large consumers of drugs, such as the NHS and health maintenance organisations in the US, are playing an increasing role in influencing the actions of pharmaceutical companies. As budgets are cut and healthcare reform gets under way many are buying or recommending only drugs that have a proven record and are cost-effective.

It is a contentious issue which was played out again last week as the storm continued over Roche's new bowel cancer drug, Avastin. The UK's healthcare cost agency – the National Institute for Health and Clinical Excellence (Nice) – has rejected the drug again, saying it is too expensive despite the manufacturers having offered new terms. Andrew Dillon, chief executive of Nice, said: "We have to be confident that the benefits justify the considerable cost of this drug."

Steve Arlington, a partner at PwC, says the "payer agenda" is "much more powerful now than ever before". He says the industry has to participate in the debate on healthcare funding and demonstrate the value of its products.

So is it all doom and gloom?

At $518bn, the size of the pharmaceutical industry is still significant; it could grow to between $800bn and $1.3trn by 2020.

Global census figures suggest that future consumer demand could be strong. The United Nations projects that the world's population will grow from 6.5 billion in 2005 to 7.6 billion by 2020. Of that, around 719.4 million, or 9.4 per cent, will be 65 or older – up from 477.4 million two years ago.

The "grey factor" boosts the need for medicines dramatically, with the UK Department of Health stating that four in five people aged over 75 take at least one prescription product, while more than a third take four drugs or more.

PwC says that diseases once more usually associated with developed countries – such as hypertension (high blood pressure) and diabetes – are also increasing in developing markets. It says that in 2004 there were 639 million people in the developing world with hypertension, a figure that is forecast to reach one billion by 2025.

http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/12/big-pharma-kisses-its-blockbuster-years.html

Disclaimer- The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

]]><![CDATA[Apotex Vs Astra Zeneca : Court Finds AstraZeneca Patent To Esomeprazole (NEXIUM) Invalid For Lack Of Sound Prediction And Obviousness.]]>Sun, 19 Dec 2010 04:00:58 GMThttp://www.drshrutibhat.com/2/post/2010/12/apotex-vs-astra-zeneca-court-finds-astrazeneca-patent-to-esomeprazole-nexium-invalid-for-lack-of-sound-prediction-and-obviousness1.html

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